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Not able to recruit sufficient participants during the funding period.
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| Name | Class |
|---|---|
| American Occupational Therapy Foundation | OTHER |
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The purpose of this project is to study how to adapt and implement the 3-Step Workout for Life program in a local home health agency. A series of learning cycles will be conducted to adjust the treatment dose and delivery mode. The specific aim is to evaluate the implementation-related clinical and patient outcomes.
Medicare beneficiaries admitted to home health agencies are often in frail status with decreased muscle strength and difficulty in performing activities of daily living. The purpose of the proposed research is to study how to adapt and implement the 3-Step Workout for Life program by the physical therapy and occupational therapy practitioners in a local home health agency. A series of learning cycles will be conducted to adjust the treatment dose and delivery mode, so that the program can be implemented at low cost but remains effective in improving self-care ability for Medicare beneficiaries. The specific aim is to evaluate the implementation-related clinical and patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation Arm | Experimental | Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-Step Workout for Life | Other | Participants will receive the modified 3-step Workout for Life program given by their physical therapy or occupational therapy providers. The program includes single-joint and multiple joint progressive resistance exercise and activities of daily living exercise. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and/or lower extremity. During the activities of daily living exercise, participants will practice activities of daily living that they experience difficulty. The intervention volume, duration, and frequency will be modified to enhance practicality in a home health care setting over the implementation phase. In addition to the 3-Step Workout for Life exercise, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care | The self-care measure is from the OASIS. It evaluates the degree of independence in seven activities: eating, oral hygiene, toileting hygiene, upper body dressing, lower body dressing, showering/bathing, and putting on/removing footwear. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). A ratio score is calculated as the sum of attempted activity scores divided by the maximal total score of attempted activities. For example, if the participant is dependent on all six self-care activities, the ratio score of this participant is 0.17 (= 7*1/7*6). The ratio score of OASIS self-care ranges from 0.17 (totally dependent on all self-care activities) to 1 (totally independent of all self-care activities). A higher ratio score means a higher ability to perform self-care. | Discharge, on average 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility | The mobility measure from OASIS evaluates the degree of independence in 17 mobility activities, such as roll left and right or sit to lying. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). A ratio score is calculated as the sum of attempted activity scores divided by the maximal total score of attempted activities. For example, if the participant is dependent on all 17 mobility activities, the ratio score of this participant is 0.17= 0.06 (17*1/17*6). The ratio score of OASIS mobility ranges from 0.17 (totally dependent on all mobility activities) to 1 (totally independent of all mobility activities). A higher ratio score means a higher ability to perform mobility tasks independently. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chiung-ju Liu, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26583695 | Background | Liu CJ, Jones LY, Formyduval A RM, Clark DO. Task-Oriented Exercise to Reduce Activities of Daily Living Disability in Vulnerable Older Adults: A Feasibility Study of the 3-Step Workout for Life. J Aging Phys Act. 2016 Jul;24(3):384-92. doi: 10.1123/japa.2015-0070. Epub 2015 Nov 19. | |
| 28769559 | Background | Liu CJ, Xu H, Keith NR, Clark DO. Promoting ADL independence in vulnerable, community-dwelling older adults: a pilot RCT comparing 3-Step Workout for Life versus resistance exercise. Clin Interv Aging. 2017 Jul 19;12:1141-1149. doi: 10.2147/CIA.S136678. eCollection 2017. |
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Of 10 enrolled patients, all received the modified 3-Step Workout for Life program.
Participants were recruited from two offices of a local home health agency. The home health therapy staff screened and referred eligible home health patients between April 2022 and March 2023. The first eligible participant was enrolled on May 26, 2022, and the last was enrolled in February 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Implementation Arm | Participants received the modified 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 3-Step Workout for Life: Participants received the 3-step Workout for Life program given by their physical therapy or occupational therapy providers. The program includes single-joint and multiple joint progressive resistance exercise and activities of daily living exercise training. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and lower extremity. During the activities of daily living exercise, participants will practice activities of daily living that they experience difficulty. The intervention volume, duration, and frequency will be modified to enhance practicality in a home health care setting over the implementation phase. In addition to the 3-Step Workout for Life, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implementation Arm | Participants will receive the modified 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 3-Step Workout for Life: Participants will receive the modified 3-step Workout for Life program given by their physical therapy or occupational therapy providers. The program includes single-joint and multiple joint progressive resistance exercise and activities of daily living exercise. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and/or lower extremity. During the activities of daily living exercise, participants will practice activities of daily living that they experience difficulty. The intervention volume, duration, and frequency will be modified to enhance practicality in a home health care setting over the implementation phase. In addition to the 3-Step Workout for Life exercise, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care | The self-care measure is from the OASIS. It evaluates the degree of independence in seven activities: eating, oral hygiene, toileting hygiene, upper body dressing, lower body dressing, showering/bathing, and putting on/removing footwear. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). A ratio score is calculated as the sum of attempted activity scores divided by the maximal total score of attempted activities. For example, if the participant is dependent on all six self-care activities, the ratio score of this participant is 0.17 (= 7*1/7*6). The ratio score of OASIS self-care ranges from 0.17 (totally dependent on all self-care activities) to 1 (totally independent of all self-care activities). A higher ratio score means a higher ability to perform self-care. | Posted | Mean | Standard Deviation | Ratio | Discharge, on average 2 months |
|
Two months
The study therapy staff will check and record the adverse events of each patient and document the events. An "adverse event" is any untoward medical occurrence in a patient, not necessarily have a causal relationship with the study. A "serious adverse event" is any untoward medical occurrence that: a) results in death, b) is life-threatening, c) requires hospitalization or prolongation of existing hospitalization, or d) results in persistent or significant disability or incapacity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implementation Arm | Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 3-Step Workout for Life: Participants will receive the modified 3-step Workout for Life program given by their physical therapy or occupational therapy providers. The program includes single-joint and multiple joint progressive resistance exercise and activities of daily living exercise. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and/or lower extremity. During the activities of daily living exercise, participants will practice activities of daily living that they experience difficulty. The intervention volume, duration, and frequency will be modified to enhance practicality in a home health care setting over the implementation phase. In addition to the 3-Step Workout for Life exercise, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anticipated adverse event | Musculoskeletal and connective tissue disorders | Muscle soreness | Systematic Assessment | Muscle soreness and/or joint pain |
Not able to meet the recruitment goal within the funding period, leading to small number of participants analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chiung-ju (CJ) Liu | University of Florida | 352-273-6496 | c.liu1@phhp.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2022 | Feb 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Discharge, on average 2 months |
| EuroQoL (European Quality of Life) | EuroQoL is a self-reported quality of life measure. The EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. An index score ranges from -0.59 (worst health) to 1 (best health). The EQ VAS (EuroQol_visual analogue scale) records the patient's self-rated health on a vertical visual analog scale ranging from 0 to 100. A higher score indicates better self-perceived health status. | Discharge, on average 2 months |
| Activity Measure of Post-Acute Care-Home Health Version | The measure evaluates the degree of difficulty in performing tasks in three domains: basic mobility, daily activities, and cognitive tasks. The raw score under each domain is then converted to a standardized T-scale score. According to the testing manual, the T-scale score range for basic mobility is from 30.36 to 70.71, for daily activities is from 22.45 to 61.92, and for applied cognition is from 9.89 to 49.40. A higher score indicates a better mobility, daily activities, or functional cognition performance. The manual does not provide information on clinically relevant thresholds or mean/SD of the T-scale. | Discharge, on average 2 months |
| 32073464 | Background | Liu CJ, Donovan J, Wolford CL. Feasibility of staff-led 3-Step Workout for Life to reduce late-life activities of daily living disability: a community-based translational study. Int J Rehabil Res. 2020 Jun;43(2):141-147. doi: 10.1097/MRR.0000000000000396. |
| Years |
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| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ratio OASIS (Outcome and Assessment Information Set): Self-care and mobility | The self-care and mobility measures are obtained from the OASIS (Outcome and Assessment Information Set). Each measure is indicated by a ratio score. A ratio score is calculated as the sum of attempted activity scores divided by the maximal total score of attempted activities. Each ratio score ranges from 0.17 to 1. A higher ratio score means a higher ability to independently perform self-care or mobility tasks. | Mean | Standard Deviation | Ratio |
|
| Activity Measure of Post-Acute Care-Home Health Version | To assess the degree of difficulty in performing tasks in three domains: basic mobility, daily activities, and cognitive tasks. The raw score under each domain is then converted to a standardized T-scale score. According to the testing manual, the T-scale score range for basic mobility is from 30.36 to 70.71, for daily activities is from 22.45 to 61.92, and for applied cognition is from 9.89 to 49.40. A higher score indicates a better mobility, self-care, or functional cognition performance. The manual does not provide information on clinically relevant thresholds or mean/SD of the T-scale. | Mean | Standard Deviation | T-scale score |
|
| European Quality of Life 5 Dimensions | European Quality of Life 5 Dimensions (EuroQol) is a self-reported quality of life measure, which includes two parts. The EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. An index score ranges from -0.59 (worst health) to 1 (best health). The EuroQol-visual analogue scales (EQ-VA) records the patient's self-rated health on a vertical visual analog scale ranging from 0 to 100. A higher score indicates better self-perceived health status. | Mean | Standard Deviation | units on a scale |
|
Participants will receive the modified 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 3-Step Workout for Life: Participants will receive the modified 3-step Workout for Life program given by their physical therapy or occupational therapy providers. The program includes single-joint and multiple joint progressive resistance exercise and activities of daily living exercise. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and/or lower extremity. During the activities of daily living exercise, participants will practice activities of daily living that they experience difficulty. The intervention volume, duration, and frequency will be modified to enhance practicality in a home health care setting over the implementation phase. In addition to the 3-Step Workout for Life exercise, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery. |
|
|
|
| Secondary | Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility | The mobility measure from OASIS evaluates the degree of independence in 17 mobility activities, such as roll left and right or sit to lying. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). A ratio score is calculated as the sum of attempted activity scores divided by the maximal total score of attempted activities. For example, if the participant is dependent on all 17 mobility activities, the ratio score of this participant is 0.17= 0.06 (17*1/17*6). The ratio score of OASIS mobility ranges from 0.17 (totally dependent on all mobility activities) to 1 (totally independent of all mobility activities). A higher ratio score means a higher ability to perform mobility tasks independently. | Posted | Mean | Standard Deviation | Ratio | Discharge, on average 2 months |
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|
|
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| Secondary | EuroQoL (European Quality of Life) | EuroQoL is a self-reported quality of life measure. The EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. An index score ranges from -0.59 (worst health) to 1 (best health). The EQ VAS (EuroQol_visual analogue scale) records the patient's self-rated health on a vertical visual analog scale ranging from 0 to 100. A higher score indicates better self-perceived health status. | Posted | Mean | Standard Deviation | score on a scale | Discharge, on average 2 months |
|
|
|
|
| Secondary | Activity Measure of Post-Acute Care-Home Health Version | The measure evaluates the degree of difficulty in performing tasks in three domains: basic mobility, daily activities, and cognitive tasks. The raw score under each domain is then converted to a standardized T-scale score. According to the testing manual, the T-scale score range for basic mobility is from 30.36 to 70.71, for daily activities is from 22.45 to 61.92, and for applied cognition is from 9.89 to 49.40. A higher score indicates a better mobility, daily activities, or functional cognition performance. The manual does not provide information on clinically relevant thresholds or mean/SD of the T-scale. | Posted | Mean | Standard Deviation | T-scale score | Discharge, on average 2 months |
|
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
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| Fall | Musculoskeletal and connective tissue disorders | Fall | Systematic Assessment | Fall |
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| Title | Measurements |
|---|---|
|